Pediatric Heart Network (PHN) Data Coordinating Center

Pediatric Heart Network (PHN) Data Coordinating Center is sponsored by National Heart, Lung, and Blood Institute (NHLBI). Supports the Data Coordinating Center for the Pediatric Heart Network, focusing on pediatric cardiovascular disease research.

Expired RFA-HL-24-002: Limited Competition: Pediatric Heart Network for the Data Coordinating Center (U24 Clinical Trial Not Allowed) This notice has expired. Check the NIH Guide for active opportunities and notices. Department of Health and Human Services Part 1.

Overview Information Participating Organization(s) National Institutes of Health ( NIH ) Components of Participating Organizations National Heart, Lung, and Blood Institute ( NHLBI ) Funding Opportunity Title Limited Competition: Pediatric Heart Network for the Data Coordinating Center (U24 Clinical Trial Not Allowed) U24 Resource-Related Research Projects Cooperative Agreements NOT-OD-22-195 - New NIH "FORMS-H" Grant Application Forms and Instructions Coming for Due Dates on or after January 25, 2023 NOT-OD-22-189 - Implementation Details for the NIH Data Management and Sharing Policy NOT-OD-22-198 - Implementation Changes for Genomic Data Sharing Plans Included with Applications Due on or after January 25, 2023 NOT-OD-23-012 - Reminder: FORMS-H Grant Application Forms & Instructions Must be Used for Due Dates On or After January 25, 2023 - New Grant Application Instructions Now Available Funding Opportunity Announcement (FOA) Number Companion Funding Opportunity Research Project with Complex Structure Cooperative Agreement See Section III.

3. Additional Information on Eligibility . Assistance Listing Number(s) 93.

837, 93. 838, 93. 233, 93.

839, 93. 840 Funding Opportunity Purpose This limited competition Funding Opportunity Announcement (FOA) is to support the Data Coordinating Center (DCC) for the Pediatric Heart Network ( https://www. pediatricheartnetwork.

org/ ). Only the current Pediatric Heart Network (PHN) DCC awardee is eligible to apply in response to this FOA. The DCC and the Clinical Research Centers (CRCs; see companion FOA RFA-HL-24-001 )) will support and conduct research to improve the health and quality of life for children and adults with congenital heart disease, and children with acquired heart disease through multi-center collaborative clinical research.

Collaboration among the CRCs, the DCC, and other stakeholders is expected to facilitate multi-center evaluation of medical, interventional, and surgical therapies; support development of novel treatment techniques and methodologies; identify and attempt to address equity gaps in outcomes; provide a training platform for fellows, junior faculty, and nurses; and promote dissemination and implementation of study results to improve the scientific basis for the care of affected individuals.

Open Date (Earliest Submission Date) Letter of Intent Due Date(s) Renewal / Resubmission / Revision (as allowed) All applications are due by 5:00 PM local time of applicant organization. Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

Required Application Instructions It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide , except where instructed to do otherwise (in this FOA or in a Notice from NIH Guide for Grants and Contracts ). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced.

Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV . When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Part 1. Overview Information Part 2. Full Text of Announcement Section I.

Funding Opportunity Description Section II. Award Information Section III. Eligibility Information Section IV.

Application and Submission Information Section V. Application Review Information Section VI. Award Administration Information Section VII.

Agency Contacts Section VIII. Other Information Part 2. Full Text of Announcement Section I.

Funding Opportunity Description This limited competition Funding Opportunity Announcement (FOA) is to support the Data Coordinating Center (DCC) for the Pediatric Heart Network (PHN) ( https://www. pediatricheartnetwork. org/ ), whose mission is to improve the health of children and adults with structural congenital heart defects, as well as children with acquired heart disease through multi-center clinical research.

A companion FOA for Clinical Research Centers (CRCs) is available; see RFA-HL-24-001 Pediatric Heart Network Clinical Research Centers (UM1 Clinical Trial Optional). Background and Objectives Congenital cardiac malformations affect about 1% of live births and are the primary cause of death under age 1 due to a birth defect.

Due to improved surgical and management techniques, survival has increased significantly in recent decades, and the number of adults living with congenital heart disease is now approximately twice the number of affected children. Acquired heart disease affects thousands of additional children each year. The PHN has been a research enterprise since 2001 with established best practices for multi-center research in pediatric cardiology.

During this funding cycle, the PHN will retain its infrastructure consisting of a DCC and up to nine CRCs. The PHN FOAs will support this infrastructure for seven years, including a number of trials and other studies as permitted by the budget. PHN investigators will be encouraged to seek funding for additional trials and studies through investigator-initiated grants, industry participation, and foundation grants.

The DCC will work with NHLBI, the CRCs, and other stakeholders to improve patient outcomes through clinical trials and other clinical studies of congenital heart disease in children and adults and of pediatric acquired heart disease.

The objectives for this limited competition FOA are to address a comprehensive plan to provide overall project coordination, administration, data management, and bolster biostatistical support, while emphasizing patient engagement, equity, and collaboration with multiple sites and other research entities through data science strategies.

In particular, this FOA seeks an application, from the current PHN DCC, that proposes activities to meet the following broad goals: Overall management of scientific activities related to study development, trial launch, and results dissemination Development and implementation of a plan for diversity, equity, and inclusion for the PHN, both in terms of the science and of the investigators involved in the PHN Development and implementation of a plan for patient and family engagement in PHN studies Development and implementation of a data science approach to research questions across the PHN Management of PHN core administration activities Coordination of logistical and other support services Organization and Governance The PHN is a cooperative Network of CRCs, a DCC, an independent Protocol Review Committee, a Data and Safety Monitoring Board (DSMB) and NHLBI Project Scientists.

The CRCs are supported by a separate award, described in detail in RFA-HL-24-001 . The DCC is expected to participate in a cooperative and interactive manner with the CRCs and NHLBI.

CRCs are responsible for proposing, developing, and refining protocols; identifying, recruiting and retaining study participants including those NIH-designated health disparity populations such as American Indians/Alaska Natives, Asian Americans, Blacks/African Americans, Hispanics/Latinos, Native Hawaiians and other Pacific Islanders, sexual and gender minorities, socioeconomically disadvantaged populations, and underserved rural populations ; entering data promptly and accurately into the electronic data capture system; contributing to manuscripts and otherwise disseminating research findings; and contributing to PHN governance through committee participation.

The Executive Committee is the main governing body of the PHN and is composed of the Principal Investigators (PIs) of the core CRCs and the DCC, the chairs of select PHN Committees, a Study Coordinator and the NHLBI Project Scientists. Each member has one vote; the NHLBI staff has one collective vote.

The Steering Committee consists of PHN investigators from all sites (the 9 main CRCs funded through this FOA and auxiliary sites funded through subcontracts with the DCC to support recruitment in specific studies) , the DCC, and NHLBI staff. PHN investigators, study coordinators, DCC statisticians and staff, and NHLBI staff meet in person an average of twice a year and by teleconference on a monthly basis, as needed.

The DCC supports protocol development; provides sample size calculations, sophisticated statistical advice, and data analysis; supports manuscript preparation; and provides overall study coordination and quality assurance, including coordination of the activities of the DSMB and other standing committees.

Funds to support the patient care costs associated with the protocols will be part of the DCC award and will be distributed to the CRCs by the DCC on a per-patient basis and according to the approved protocol budgets. The PHN's scientific and administrative work is assisted by a variety of committees whose membership is drawn from the CRCs, the DCC, and the NHLBI.

Committees may include protocol development, publications, finance, core lab, ancillary studies, nursing research, biospecimens, health services research, and other committees as needed to support PHN activities. NHLBI is responsible for strategic direction and support for the PHN. The NHLBI Program Office and Office of Grants Management are responsible for the overall management.

In addition to regular grant stewardship, the NHLBI Project Scientists will be involved substantially with the awardees as a scientific partner, consistent with the Cooperative Agreement mechanism. The PHN’s NHLBI-appointed DSMB monitors patient safety and reviews performance of each study.

As a part of its monitoring responsibility, the DSMB submits recommendations to the NHLBI regarding the conduct and continuation of each protocol. Participation in/Selection of Trials Multiple trials and other clinical studies will be conducted during the project period. Once the CRCs are convened in the new funding cycle, the PHN Executive and Steering Committees will consider proposed protocols and prioritize them.

It is expected that each approved protocol will be implemented in all of the core CRCs. The ability to conduct specific protocols will depend on scientific priority and the availability of funds. Sites will be reimbursed to conduct the protocols on a capitated basis.

The DCC will manage approval of clinical protocols by the PHN’s single IRB. The number of protocols supported in the program will depend on the nature and extent of the investigations proposed and on available funds. Both short and long-term projects will be considered.

Notice of NIH's Interest in Diversity Every facet of the United States scientific research enterprise from basic laboratory research to clinical and translational research to policy formation requires superior intellect, creativity and a wide range of skill sets and viewpoints.

NIH’s ability to help ensure that the nation remains a global leader in scientific discovery and innovation is dependent upon a pool of highly talented scientists from diverse backgrounds who will help to further NIH's mission. Research shows that diverse teams working together and capitalizing on innovative ideas and distinct perspectives outperform homogenous teams.

Scientists and trainees from diverse backgrounds and life experiences bring different perspectives, creativity, and individual enterprise to address complex scientific problems.

There are many benefits that flow from a diverse NIH-supported scientific workforce, including: fostering scientific innovation, enhancing global competitiveness, contributing to robust learning environments, improving the quality of the research, advancing the likelihood that underserved or health disparity populations participate in, and benefit from health research, and enhancing public trust.

In spite of tremendous advancements in scientific research, information, educational and research opportunities are not equally available to all. NIH encourages institutions to diversify their student and faculty populations to enhance the participation of individuals from groups that are underrepresented in the biomedical, clinical, behavioral and social sciences.

See NOT-OD-20-031 and Reminder: Notice of NIH's Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities NOT-OD-22-019 for details. To support the best science, the PHN encourages inclusivity in research.

Examples of structures that promote diverse perspectives include but are not limited to: Transdisciplinary research projects and collaborations among neuroscientists and researchers from fields such as computational biology, physics, engineering, mathematics, computer and data sciences, as well as bioethics.

Engagement from different types of institutions and organizations (e.g., research-intensive, undergraduate-focused, minority-serving, community-based). Individual applications and partnerships that enhance geographic and regional heterogeneity. Investigators and teams composed of researchers at different career stages.

Participation of individuals from diverse backgrounds, including groups traditionally underrepresented in the biomedical, behavioral, and clinical research workforce (see NOT-OD-20-031 ), such as underrepresented racial and ethnic groups, those with disabilities, those from disadvantaged backgrounds, and women. Project-based opportunities to enhance the research environment to benefit early- and mid-career investigators.

Plan for Enhancing Diverse Perspectives (PEDP) This FOA requires a Plan for Enhancing Diverse Perspectives (PEDP) as part of the application (see further below). Applicants are strongly encouraged to read the FOA instructions carefully and view the available PEDP guidance material . Applications must include a Plan for Enhancing Diverse Perspectives (PEDP) submitted as Other Project Information as an attachment (see Section IV ).

The PEDP will be assessed as part of the scientific and technical peer review evaluation, as well as considered among programmatic matters with respect to funding decisions. See Section VIII. Other Information for award authorities and regulations.

Section II. Award Information Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities.

See Section VI. 2 for additional information about the substantial involvement for this FOA. Application Types Allowed The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.

Only those application types listed here are allowed for this FOA. Not Allowed: Only accepting applications that do not propose clinical trials. Need help determining whether you are doing a clinical trial?

Funds Available and Anticipated Number of Awards The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications. NHLBI intends to commit total costs of up to $3,200,000 in Fiscal Year 2024 to fund one new award.

Application budgets must not exceed $2,105,263 direct costs in Fiscal Year 2024, $3,552,632 direct costs in Fiscal Year 2025, $4,473,684 direct costs in Fiscal Years 2026 and 2027, $4,223,684 direct costs in Fiscal Year 2028, $3,565,789 direct costs in Fiscal Year 2029, and $2,276,316 direct costs in Fiscal Year 2030. The scope of the proposed project should determine the project period. The maximum project period is 7 years.

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this FOA. Section III.

Eligibility Information Higher Education Institutions Public/State Controlled Institutions of Higher Education Private Institutions of Higher Education The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education: Hispanic-serving Institutions Historically Black Colleges and Universities (HBCUs) Tribally Controlled Colleges and Universities (TCCUs) Alaska Native and Native Hawaiian Serving Institutions Asian American Native American Pacific Islander Serving Institutions (AANAPISIs) Nonprofits Other Than Institutions of Higher Education Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education) Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education) For-Profit Organizations (Other than Small Businesses) City or Township Governments Special District Governments Indian/Native American Tribal Governments (Federally Recognized) Indian/Native American Tribal Governments (Other than Federally Recognized) Eligible Agencies of the Federal Government U.S. Territory or Possession Independent School Districts Public Housing Authorities/Indian Housing Authorities Native American Tribal Organizations (other than Federally recognized tribal governments) Faith-based or Community-based Organizations Eligibility is limited to the current recipient of the NHLBI-funded PHN Data Coordinating Center award ( RFA-HL-11-027 ).

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply. Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement , are not allowed.

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible.

The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission. System for Award Management (SAM) Applicants must complete and maintain an active registration, which requires renewal at least annually . The renewal process may require as much time as the initial registration.

SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code. NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM. Unique Entity Identifier (UEI)- A UEI is issued as part of the SAM.

gov registration process. The same UEI must be used for all registrations, as well as on the grant application. eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants.

gov registration; all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application. Grants.

gov Applicants must have an active SAM registration in order to complete the Grants. gov registration. Program Directors/Principal Investigators (PD(s)/PI(s)) All PD(s)/PI(s) must have an eRA Commons account.

PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

Eligible Individuals (Program Director/Principal Investigator) Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support.

Individuals from diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support. See, Reminder: Notice of NIH's Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities, NOT-OD-22-019 .

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

The PD(s)/PI(s) must possess advanced degrees in relevant fields such as Network management, clinical trials, biostatistics, or epidemiology, and are required to propose and commit percent effort commensurate with the DCC activities. This FOA does not require cost sharing as defined in the NIH Grants Policy Statement . 3.

Additional Information on Eligibility Applicant organizations may submit more than one application, provided that each application is scientifically distinct. The NIH will not accept duplicate or highly overlapping applications under review at the same time, per 2. 3.

7. 4 Submission of Resubmission Application . This means that the NIH will not accept: A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.

A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application. An application that has substantial overlap with another application pending appeal of initial peer review (see 2. 3.

9. 4 Similar, Essentially Identical, or Identical Applications ). Section IV.

Application and Submission Information 1. Requesting an Application Package The application forms package specific to this opportunity must be accessed through ASSIST, Grants. gov Workspace or an institutional system-to-system solution.

Links to apply using ASSIST or Grants. gov Workspace are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

2. Content and Form of Application Submission It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced.

Applications that are out of compliance with these instructions may be delayed or not accepted for review. All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed. Instructions for Application Submission The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.

Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H application forms packages. All instructions in the SF424 (R&R) Application Guide must be followed. SF424(R&R) Project/Performance Site Locations All instructions in the SF424 (R&R) Application Guide must be followed.

SF424(R&R) Other Project Information All instructions in the SF424 (R&R) Application Guide must be followed. Plan for Enhancing Diverse Perspectives (PEDP) In an "Other Attachment" entitled "Plan for Enhancing Diverse Perspectives," all applicants must include a summary of strategies to advance the scientific and technical merit of the proposed project through expanded inclusivity.

The PEDP should provide a holistic and integrated view of how enhancing diverse perspectives is viewed and supported throughout the application and can incorporate elements with relevance to any review criteria (significance, investigator(s), innovation, approach, and environment) as appropriate. Where possible, applicant(s) should align their description with these required elements within the research strategy section.

The PEDP will vary depending on the scientific aims, expertise required, the environment and performance site(s), as well as how the project aims are structured. The PEDP may be no more than 1-page in length and should include a timeline and milestones for relevant components that will be considered as part of the review.

Examples of items that advance inclusivity in research and may be part of the PEDP can include, but are not limited to: Discussion of engagement with different types of institutions and organizations (e.g., research-intensive, undergraduate-focused, minority-serving, community-based). Description of any planned partnerships that may enhance geographic and regional diversity.

Plan to enhance recruiting of women and individuals from groups traditionally under-represented in the biomedical, behavioral, and clinical research workforce. Proposed monitoring activities to identify and measure PEDP progress benchmarks. Plan to utilize the project infrastructure (i.e., research and structure) to support career-enhancing research opportunities for diverse junior, early- and mid-career researchers.

Description of any training and/or mentoring opportunities available to encourage participation of students, postdoctoral researchers and co-investigators from diverse backgrounds. Plan to develop transdisciplinary collaboration(s) that require unique expertise and/or solicit diverse perspectives to address research question(s). Publication plan that enumerates planned manuscripts and proposed lead authorship.

Outreach and planned engagement activities to enhance recruitment of individuals from diverse groups as research participants including those from under-represented backgrounds. SF424(R&R) Senior/Key Person Profile All instructions in the SF424 (R&R) Application Guide must be followed. A mulit-PI plan is encouraged.

Key personnel should demonstrate strong clinical trials, biostatistics, data science, administrative, technical, and project management expertise and any other expertise critical to the success of the PHN. Active participation of the PD(s)/PI(s) is expected during all phases of PHN operations. All instructions in the SF424 (R&R) Application Guide must be followed.

Application budgets must plan for the following: For all non-protocol costs , applicants may request no more than $2,105,263 direct costs in Fiscal Year 2024, $3,552,632 direct costs in Fiscal Year 2025, $4,473,684 direct costs in Fiscal Years 2026 and 2027, $4,223,684 direct costs in Fiscal Year 2028, $3,565,789 direct costs in Fiscal Year 2029, and $2,276,316 direct costs in Fiscal Year 2030.

Non-protocol costs should include $300,000 in direct costs for each Fiscal Year for 2025, 2027 and 2029 for clinical research skills development and $150,000 for each Fiscal Year (2024-2030) for CORE training and Career Day.

For protocol development and conduct , applicants should include $12,000,000 as outlined here: $1,000,000 direct costs in Fiscal Year 2024 and $2,000,000 direct costs in Fiscal Year 2025, $2,500,000 in Fiscal Years 2026 and 2027, and $2,000,000 in Fiscal Years 2028, and 2029 .

For PEDP implementation costs, a pplicants may include allowable costs associated with PEDP implementation (as outlined in the Grants Policy Statement section 7: https://grants. nih. gov/grants/policy/nihgps/html5/section_7/7.

1_general. htm ). All instructions in the SF424 (R&R) Application Guide must be followed.

PHS 398 Cover Page Supplement All instructions in the SF424 (R&R) Application Guide must be followed. All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions: Research Strategy : The DCC will have substantial responsibility for the performance of PHN research and awardees.

Describe the planned approach to achieving the following: Direct multi-center collaboration in pediatric and adult congenital and pediatric acquired heart disease clinical trials and studies; Develop community engagement strategies for the PHN that encourage diversity, equity, and inclusion amongst the research and study participants.

; Manage and collaborate in the development, implementation, and monitoring of PHN protocols from inception through data dissemination; Serve as a state-of-the-art research data management center, including developing and maintaining robust systems for electronic data capture, quality control, monitoring of protocol and site performance, and reimbursement of sites; Support data integration activities for data from PHN studies combined with data from other sources, such as non-PHN registries and mobile health platforms; Support data ingestion through dbGaP and NHLBI’s BioData Catalyst; Provide robust, sophisticated clinical trials and biostatistical support during the development, execution, and completion of all study protocols; Set, monitor, and report on milestones for study performance; Develop multimedia, multilingual recruitment tools; Collaborate in the analysis of data and publication of the results of trials and studies; Provide efficient report generation, including preparation of data and safety reports for the PHN’s Data and Safety Monitoring Board, preparation of demographic reports guided by the NIH Inclusion policies on the diversity of study enrollment ; and preparation of other data reports as needed; Manage the PHN’s single IRB and collect and file all Institutional Review Board (IRB) reports and communications; Prepare patient capitation budgets,monitor the ongoing expenditure of protocol funds, and prepare reports as requested; Prepare and file all regulatory documents required for studies conducted under FDA or EMA auspices and hold INDs or IDEs as needed for specific trials; Provide periodic recruitment data through the NHLBI Clinical Dashboard for all ongoing studies at intervals appropriate to the study; Organize and provide necessary training for PHN protocols; Conduct all necessary monitoring and quality assurance activities, including site visits as needed, and remote monitoring consistent with FDA guidance; Provide a system for active monitoring of all PHN publications in progress, including regular reminders for authors and writing groups to ensure that PHN publication metrics are achieved; Efficiently prepare public-use data sets and manage requests and inquiries related to data; and Maintain and update the PHN website to include information about studies and summaries of study results.

Manage Core PHN operations Organize and manage meetings and calls for the Steering Committee, Executive Committee, Data and Safety Monitoring Board, Protocol Development Committees and other committees essential to the conduct of the PHN; Maintain the infrastructure necessary to support all PHN activities, including virtual meeting capabilities, electronic billing and payment capabilities, and maintenance of the public and administrative PHN websites and electronic data capture systems; Describe flexible staffing approaches to respond to the changing needs and seasonal variation in work effort of the PHN; Execute master site services agreements and protocol agreements with all CRCs including non-PHN auxiliary sites when needed; Handle travel arrangements for consultants as needed; Issue Requests for Proposals, coordinate selection and execute subcontracts for core labs and other resources as required by each study.

Applications are encouraged to describe special or unique strengths that may be relevant to the research conducted by the PHN. These can include systems, tools, or other resources that can be brought to bear to develop and expand the scientific productivity of the PHN.

In addition, special administrative strengths or experience as well as participation in aspects of clinical research (IRB, DSMB, scientific board for clinical research, clinical research committees, etc.) for the PD/PI and additional staff members should be highlighted. Past levels of support for clinical trials should be described.

The following modifications also apply: All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan. Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H application forms packages.

All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan. All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan. Only limited Appendix materials are allowed.

Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

PHS Human Subjects and Clinical Trials Information When involving human subjects research, clinical research, and/or NIH-defined clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions: If you answered Yes to the question Are Human Subjects Involved?

on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record. Study Record: PHS Human Subjects and Clinical Trials Information All instructions in the SF424 (R&R) Application Guide must be followed.

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the SF424 (R&R) Application Guide must be followed. PHS Assignment Request Form All instructions in the SF424 (R&R) Application Guide must be followed.

3. Unique Entity Identifier and System for Award Management (SAM) See Part 1. Section III.

1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants. gov. 4. Submission Dates and Times Part I.

Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday